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NCT05671653 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Effect of the Experimental GLP-1 Drug PF-07081532 on Blood Levels of Common Birth Control Pills, and Drugs Omeprazole and Midazolam, and Effect of GLP-1 Drug Semaglutide on Midazolam Blood Levels in Healthy Adults With Weight in the Obesity Range
A Phase 1 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT05671653: Clinical Trial Phase 1 study, sponsored by Pfizer.
NCT05671653 is a Phase 1 study that was terminated before completion, run by Pfizer. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05671653, a Phase 1 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
Two different groups of healthy volunteers will be chronically treated with GLP-1 drugs PF-07081532 or alternatively Semaglutide. The effect of these GLP-1 drugs on a single dose of the common sedative medication midazolam blood levels will be measured. The effect of chronic PF-07081532 on single doses of the common stomach acid medication omeprazole, and common birth control medication blood levels will also be measured. The hypothesis is that chronic administration of the GLP-1 drugs will minimally affect blood levels from these common medications.
Primary Outcome
Midazolam was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for midazolam pharmacokinetic (PK) at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Interventions
- DRUG Semaglutide
- DRUG PF-07081532
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2023-01-19 |
| Est. Completion | 2023-11-03 |
| Phase | Phase 1 |
Why NCT05671653 stopped before completion
NCT05671653 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Semaglutide is the first listed.
NCT05671653 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05671653 about?
NCT05671653 is a clinical study titled "A Study to Evaluate the Effect of the Experimental GLP-1 Drug PF-07081532 on Blood Levels of Common Birth Control Pills, and Drugs Omeprazole and Midazolam, and Effect of GLP-1 Drug Semaglutide on Midazolam Blood Levels in Healthy Adults With Weight in the Obesity Range". Two different groups of healthy volunteers will be chronically treated with GLP-1 drugs PF-07081532 or alternatively Semaglutide. The effect of these GLP-1 drugs on a single dose of the common sedative medication midazolam blood levels will be measured. The effect of chronic PF-07081532 on single do...
What is the current status of trial NCT05671653?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2023-01-19. Estimated completion is 2023-11-03.
What interventions are being tested in trial NCT05671653?
The interventions under investigation include: Semaglutide (DRUG), PF-07081532 (DRUG).
Who is sponsoring clinical trial NCT05671653?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05671653's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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